Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer

Wake Forest University (WFU)

Status and phase: Completed; Phase 2

Conditions: Stage IIIA Breast Cancer; Stage IB Breast Cancer; Male Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage II Breast Cancer; Stage IA Breast Cancer; Lobular Breast Carcinoma in Situ; Ductal Breast Carcinoma in Situ

Treatments: Other: laboratory biomarker analysis; Other: placebo; Drug: omega-3 fatty acid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01869764

NCI-2013-00963 (Registry Identifier)

P30CA012197 (U.S. NIH Grant/Contract)

CCCWFU 98113 (Other Identifier)

IRB00023419

Details and patient eligibility

About

This phase II clinical trial studies how well omega-3 fatty acid works in treating patients with stage I-III breast cancer. Studying samples of tissue and blood in the laboratory from breast cancer patients receiving omega-3 fatty acid may help doctors learn more about the effects of omega-3 fatty acid on tumor cells.

Full description

PRIMARY OBJECTIVES:

I. To determine if omega-3 dietary supplementation (omega-3 fatty acid) results in higher polyunsaturated fatty acids (PUFA) levels in surgical specimens of normal and malignant breast tissue in women who took omega 3 tablets in comparison to those who took placebo.

II. To determine if omega-3 dietary supplementation results in higher PUFA levels in plasma and red blood cells in women who took omega 3 tablets in comparison to those who took placebo.

III. To determine if omega-3 dietary supplementation affects the metabolites of omega-3 and omega-6 PUFA in surgical specimens of malignant and normal breast tissue in comparison to controls.

IV. To determine if women who take omega-3 dietary supplementation have less proliferation and greater apoptosis in malignant breast tissue in comparison to women who take placebo.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive omega-3 fatty acid orally (PO) daily for 7-14 days.

ARM II: Patients receive placebo PO daily for 7-14 days.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed stage I to III breast cancer and carcinoma in situ (including lobular carcinoma in situ [LCIS] and ductal carcinoma in situ [DCIS])
• Breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment
• Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved written informed consent document
• Tumor measures at least 1 centimeter on imaging or physical exam

Exclusion criteria

• Any patient with surgery scheduled < 7days after biopsy
• Patients who are unable to refrain from the use of any NSAID or full-dose acetylsalicylic acid (ASA)-containing NSAID while taking study drug
• Patients who will receive neoadjuvant chemotherapy are not eligible
• Patients who are currently taking omega-3 fatty acids, as they are unable to be randomized to placebo
• Patients who have previously taken omega-3 fatty acid within 1 month prior to study enrollment
• Patients with an allergy or known hypersensitivity to fish

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups, including a placebo group

Arm I (omega-3 fatty acid)

Experimental group

Description:

Patients receive omega-3 fatty acid PO daily for 7-14 days.

Treatment:

Drug: omega-3 fatty acid

Other: laboratory biomarker analysis

Arm II (placebo)

Placebo Comparator group

Description:

Patients receive placebo PO daily for 7-14 days.

Treatment:

Other: placebo

Other: laboratory biomarker analysis